Stroke and traumatic brain injury frequently result in persistent upper and lower limb motor impairment. While conventional rehabilitation improves outcomes, patient adherence and training intensity remain limiting factors. Immersive virtual reality (VR)-based therapy may enhance neuroplasticity by delivering high-intensity, task-oriented motor practice with enriched sensory feedback. This randomized controlled trial evaluates the efficacy and safety of the 6Degrees MyMove interactive VR system compared to passive VR exposure in individuals undergoing subacute inpatient rehabilitation after stroke or traumatic brain injury. Sixty participants will be randomized 1:1 to receive either interactive VR-based motor training or passive VR viewing, in addition to standard rehabilitation care, three times weekly for eight weeks. The primary objective is to determine whether interactive VR leads to greater improvement in motor function compared to passive VR. Secondary outcomes include dexterity, gait speed, functional independence, psychological status, adherence, usability, and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
During each session, participants will engage in goal-directed motor exercises within an immersive VR environment delivered through a head-mounted display. Tasks are designed to promote range of motion, coordination, motor control, and functional movement. The system provides real-time visual and auditory feedback and adapts task difficulty based on individual performance and motor capacity.
Participants in the control arm will receive immersive virtual reality exposure using a head-mounted display. The content will include movies, 360-degree videos, or virtual environments designed to provide audiovisual immersion without requiring active motor engagement or task performance.
Reuth Rehabilitation Hospital - Tel Aviv
Tel Aviv, Israel
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
A standardized, stroke-specific measure of upper-limb motor impairment assessing movement, coordination, and reflex activity. Scores range from 0 to 66, with higher scores indicating better motor function.
Time frame: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up
Finger Tapping Test
A performance-based assessment of upper-limb motor speed and neuromotor control. Participants are instructed to tap a key or surface as rapidly as possible with the index finger over a fixed time interval. The total number of taps is recorded, with higher scores reflecting better motor speed and coordination.
Time frame: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up
Box and Blocks Test (BBT)
A standardized measure of gross manual dexterity in which participants are instructed to transfer as many blocks as possible, one at a time, from one compartment of a box to another within 60 seconds. The total number of blocks successfully transferred is recorded. Higher scores indicate better manual dexterity.
Time frame: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up
10-Meter Walk Test (10MWT)
A performance-based measure of gait speed in which participants are instructed to walk a distance of 10 meters at a comfortable and safe pace. Walking speed is calculated in meters per second (m/s). Higher gait speed values indicate better functional mobility.
Time frame: Immediate post-intervention (8 weeks)
Five Times Sit-to-Stand Test (5xSTS)
A performance-based measure of lower-limb strength and functional mobility in which participants are instructed to rise from a seated position to standing and return to sitting five consecutive times as quickly and safely as possible. The total time required to complete the task is recorded in seconds. Lower completion times indicate better lower-limb function.
Time frame: Immediate post-intervention (8 weeks)
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